mHealth field study among community health workers in the Balaka and Salima districts of Malawi

• Register: ISRCTN
• Last refreshed on: 28 August 2023
• Main ID: ISRCTN24785657
• Date of registration: 23/07/2015
• Prospective Registration: No
• Primary sponsor: Foreign Affairs, Trade and Development Canada
• Public title: mHealth field study among community health workers in the Balaka and Salima districts of Malawi
• Scientific title: Evaluation of a mHealth data quality intervention to improve documentation of pregnancy outcomes by Health Surveillance Assistants in Malawi: a cluster randomized trial
• Date of first enrolment: 01/01/2010
• Target sample size: 160
• Recruitment status: Completed
• URL: https://www.isrctn.com/ISRCTN24785657
• Study type: Interventional
• Study design: Cluster randomized trial with an interventional design (Other)
• Phase: Not Applicable

Countries of recruitment

Malawi, United States of America

Contacts

• Name: Olga Joos

Key inclusion & exclusion criteria

Inclusion criteria: 160 HSAs, one for each of the 160 randomized catchment areas selected for the RMM study
Exclusion criteria: Not fulfilling inclusion criteria

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

We are evaluating completeness of pregnancy documentation. We define a complete pregnancy as a pregnancy with a matched outcome: live birth, transfer-out of the pregnant mother, abortion, miscarriage, or stillbirth.
Pregnancy and Childbirth

Intervention(s)

We implemented the intervention in two phases. Phase one ran for seven months between December 2012 and June 2013. Phase two ran for five months from July 2013 through November 2013. Throughout both phases, the treatment group received high-intensity SMS with motivational content and data quality content based on project guidelines. For phase one, the treatment group received SMS three times a week. During phase two held from July 2013-November 2013, the treatment group received SMS five times a week. The control group received minimal-intensity SMS with basic motivational content twice a week during the 12 month intervention period.

The intervention was randomized and designed at the cluster level, health facilities, but the SMS were received directly by HSA assigned to the health facilities. We constrained the cluster randomization of 30 health facilities using three variables to improve balance between treatment arms. Once we completed the randomization and assigned 15 health facilities to the control group and 15 health facilities to the treatment group, we verified that the spread of clusters was evenly distributed between the two study districts.

Primary Outcome(s)

An improvement in matched pregnancies during the intervention period in the treatment group compared to the control group. A matched pregnancy is defined as a pregnancy with a matched outcome: live birth, out-migration of the mother, abortion, stillbirth, or miscarriage.

Secondary Outcome(s)

An improvement in matched pregnancies between baseline and intervention periods by group. Matched pregnancies will be evaluated for the control group and treatment group separately.

Secondary ID(s)

N/A

Source(s) of Monetary Support

Foreign Affairs, Trade and Development Canada

Ethics review

Status:
Approval date:
Contact:

Old ethics approval format; 1. National Health Sciences Research Committee, 13/02/2009, ref: Protocol #617 2. Institutional Review Board at the Johns Hopkins University Bloomberg School of Public Health, 30/07/2009, ref: IRB #2247

Results

• Results available: Yes
• Date Completed: 30/03/2014